[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555653":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":30,"studyPopulation":17,"armGroups":31,"interventions":44,"overallOfficials":17,"centralContacts":17,"locations":53,"responsibleParty":70,"collaborators":17,"id":72,"slug":17,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":17,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":17,"enrollmentInfo":80,"targetDuration":17,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":55,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical outcome","Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application","24 months follow-up",[14],{"measure":15,"description":16,"timeFrame":12},"Patient-based subjective evaluation","Compare patient-based subjective evaluations on the two different approaches in treating root caries lesions.\n\nThe Chinese version of General Oral Health Assessment Index (GOHAI) will be adopted as a tool to assess the oral health-related quality of life (OHRQoL) of the participants. It contains 12 questions covering three domains: physical function, pain and discomfort, and psychosocial function. The total GOHAI score is generated by adding up the score of each response to the 12 questions, and the total score ranges from 12 to 60. A higher score indicates a better perceived OHRQoL.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","two-arm randomized controlled clinical trial","TREATMENT",{"masking":24,"maskingDescription":25,"whoMasked":26},"TRIPLE","Participants, operators and investigators will not be informed of the group allocation",[27,28,29],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries.\n\nThe objectives of the study are to\n\n1. Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application;\n2. Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.\n\nHypotheses to be tested:\n\n1. Prior SDF application increases the success rate of restorations placed in root caries;\n2. Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"SDF group","EXPERIMENTAL","Participants of SDF group will be applied with SDF before placement of root caries restoration",[37],"Other: SDF solution application",{"label":39,"type":40,"description":41,"interventionNames":42},"Control group","PLACEBO_COMPARATOR","Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration",[43],"Other: Tonic water",[45,49],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"SDF solution application","silver diamine fluoride (SDF) solution is highly effective in stopping and arresting the progress of decay in dental roots of older adults. The American Dental Association (ADA) has published a guideline based on the up-to-date evidence to support the use of SDF for managing tooth decay. As a non-invasive procedure, application of SDF is simple, quick, painless and non-aerosol generated.",[33],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":17},"Tonic water","Tonic water will be used as a placebo to mimic the SDF solution.",[39],[54],{"facility":5,"status":55,"city":56,"state":17,"zip":17,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Hong Kong","HK",{"type":59,"coordinates":60},"Point",[61,62],114.17469,22.27832,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":17,"email":69},"Chloe Jiang, PhD","CONTACT","+852-28590507","cmjiang@hku.hk",{"type":71,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100555653",false,"NCT06514885","Silver Diamine Fluoride Application on Root Caries Fillings","Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries","Inclusion Criteria:\n\n* Older adults (aged 60 or above)\n* At least one untreated decayed dental root\n\nExclusion Criteria:\n\n* No self-care ability for basic daily activities\n* Teeth with severe decay (cannot be filled)\n* Teeth indicated for extraction","ALL","60 Years",{"count":81,"type":82},184,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.\n\nThe main questions to answer\n\n1. Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;\n2. Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.\n\nParticipants will be allocated into two group\n\n1. prior SDF application before receiving root caries fillings\n2. directly receiving root caries fillings without any SDF application",[88],"Root Caries",[90,91,92,93],"silver diamine fluoride","older adults","restorative treatment","root caries","2024-12-06",{"date":96,"type":97},"2024-12-09","ACTUAL",{"date":99,"type":97},"2023-10-01",{"date":101,"type":82},"2026-10-01",{"name":5,"class":6},1]